Hogan Lovells – Policy considerations for advancing AI innovations in patient care
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As California life sciences companies advance AI technologies and grapple with how best to adapt their products and services in view of local developments, they must also be mindful of U.S. federal policy developments in this space. Among other recent developments, the Biden Administration’s October Executive Order on AI (EO) signals a clear interest in the impact of AI on the healthcare industry, which is already heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure quality and safety. Below are key areas in which we expect continued changes leading into the 2024 election and beyond.
Agency activity. The EO outlines dozens of actions, including many for which the U.S. Department of Health and Human Services (HHS) will be responsible. Additional agency activity to implement the EO will likely be forthcoming, with potential opportunities for stakeholder comment and involvement.
For example, we expect that the HHS Office of Civil Rights (OCR) will finalize regulations proposed last year which would expand the obligations for developers of AI tools under Section 1557 of the Affordable Care Act to ensure that clinical algorithms do not have a discriminatory effect. We also anticipate further agency educational efforts for providers and developers of Certified Health Information Technology regarding compliance with the HHS Office of the National Coordinator (ONC) final rule on transparency and risk mitigation activity reporting for certain AI systems.
Congressional activity. Members have expressed enthusiasm about the potential applications of AI in health care while expressing concerns regarding transparency, privacy, and bias, including AI potentially incorporating human biases and the safeguarding of patient information used to train AI models. Expect continued discussions around the incorporation of AI guardrails into existing data privacy legislation and discussion of appropriate Medicare coverage and payment for AI applications. While comprehensive legislation may be unlikely prior to the election, we expect AI to remain a top issue on Capitol Hill, including as part of upcoming appropriations bills.
Health care systems and others in the life sciences sector need to pay attention. At the federal and state levels, now is the time for stakeholders to engage in policymaking processes given the breadth of their potential impact on life sciences companies and patients. Policymakers continue to face a steep learning curve and industry perspectives will be one important key to advancing appropriate regulations in this rapidly evolving area.
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Background content:
U.S. AI policy heats up with new executive order and legislative activity – Hogan Lovells Engage
California signals intent to regulate AI broadly – Hogan Lovells Engage
Submitted by Melissa Bianchi, Beth Roberts, and Cybil Roehrenbeck, Hogan Lovells